- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00631332
Women's Health Initiative Study of Cognitive Aging (WHISCA)
Effects of Hormone Replacement Therapy on Cognitive Aging: Women's Health Initiative Study of Cognitive Aging (WHISCA)
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
WHISCA is an ancillary study to the Women's Health Initiative (WHI) and the WHI Memory Study (WHIMS) and has enrolled 2303 women aged 66 to 84 years who did not meet the criteria for dementia. WHISCA is investigating the effects of hormone therapy on rates of change over time in memory, other aspects of cognition (language, attention, spatial ability), motor function, and mood.
Objectives
- Does HT protect against age-associated memory and cognitive longitudinal decline in women age 65 and older?
- What is the rate of change in memory and other cognitive abilities in women receiving HT compared to women receiving placebo?
- Does the addition of progesterone to HT modify the effects of estrogen on memory and other cognitive abilities?
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
North Carolina
-
Winston-Salem, North Carolina, Vereinigte Staaten, 27157
- Wake Forest University School of Medicine
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Enrolled in WHIMS
- At least 65 years old
- Not diagnosed with dementia
Exclusion Criteria:
- Women younger than 65 years of age
- Have dementia
- not enrolled in WHIMS
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Determine if HT protect against age-associated memory and cognitive longitudinal decline in women age 65 and older as measured over time by a series of cognitive tests administered annually.
Zeitfenster: Annual assessment done annually.
|
The primary outcome measures are the changes in scores from a standardized neuropsychological assessment will be conducted annually.
The battery is comprised primarily of tests of memory, and includes the following tests in specified order: the Prospective Memory Tests, Primary Mental Abilities Vocabulary Test, the California Verbal Learning Test, the Benton Visual Retention Test, Card Rotations Test, the Finger Tapping Test, the Letter and Semantic Fluency Test and the Digit Span Test.
In addition, the Positive and Negative Affect Scale and Geriatric Depression Scale will be administered.
|
Annual assessment done annually.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Determine the long-term effects of HT on changes in memory, other cognitive functions, and affect; and to investigate predictors of the transitions between normal aging and mild cognitive impairment and mild cognitive impairment and dementia.
Zeitfenster: measured over life of the study
|
Secondary outcome measures will examine relative differences in measures between enrollment in WHIMS and the termination of the WHIMS E+P trial and E-Alone trial and also examine the relative differences in measures comparing periods of time for each woman when she reported taking HT versus times she reported not taking HT.
|
measured over life of the study
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Sally Shumaker, PhD, Wake Forest University Health Sciences
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Ammann EM, Pottala JV, Harris WS, Espeland MA, Wallace R, Denburg NL, Carnahan RM, Robinson JG. omega-3 fatty acids and domain-specific cognitive aging: secondary analyses of data from WHISCA. Neurology. 2013 Oct 22;81(17):1484-91. doi: 10.1212/WNL.0b013e3182a9584c. Epub 2013 Sep 25.
- Goveas JS, Espeland MA, Hogan PE, Tindle HA, Shih RA, Kotchen JM, Robinson JG, Barnes DE, Resnick SM. Depressive Symptoms and Longitudinal Changes in Cognition: Women's Health Initiative Study of Cognitive Aging. J Geriatr Psychiatry Neurol. 2014 Jun;27(2):94-102. doi: 10.1177/0891988714522697. Epub 2014 Feb 28.
- Driscoll I, Espeland MA, Wassertheil-Smoller S, Gaussoin SA, Ding J, Granek IA, Ockene JK, Phillips LS, Yaffe K, Resnick SM; Women's Health Initiative Study of Cognitive Aging. Weight change and cognitive function: findings from the Women's Health Initiative Study of Cognitive Aging. Obesity (Silver Spring). 2011 Aug;19(8):1595-600. doi: 10.1038/oby.2011.23. Epub 2011 Mar 10.
- Resnick SM, Coker LH, Maki PM, Rapp SR, Espeland MA, Shumaker SA. The Women's Health Initiative Study of Cognitive Aging (WHISCA): a randomized clinical trial of the effects of hormone therapy on age-associated cognitive decline. Clin Trials. 2004;1(5):440-50. doi: 10.1191/1740774504cn040oa.
- Espeland MA, Coker LH, Wallace R, Rapp SR, Resnick SM, Limacher M, Powell LH, Messina CR; Women's Health Initiative Study of Cognitive Aging. Association between alcohol intake and domain-specific cognitive function in older women. Neuroepidemiology. 2006;27(1):1-12. doi: 10.1159/000093532. Epub 2006 May 24.
- Resnick SM, Maki PM, Rapp SR, Espeland MA, Brunner R, Coker LH, Granek IA, Hogan P, Ockene JK, Shumaker SA; Women's Health Initiative Study of Cognitive Aging Investigators. Effects of combination estrogen plus progestin hormone treatment on cognition and affect. J Clin Endocrinol Metab. 2006 May;91(5):1802-10. doi: 10.1210/jc.2005-2097. Epub 2006 Mar 7.
- Resnick SM, Espeland MA, An Y, Maki PM, Coker LH, Jackson R, Stefanick ML, Wallace R, Rapp SR; Women's Health Initiative Study of Cognitive Aging Investigators. Effects of conjugated equine estrogens on cognition and affect in postmenopausal women with prior hysterectomy. J Clin Endocrinol Metab. 2009 Nov;94(11):4152-61. doi: 10.1210/jc.2009-1340. Epub 2009 Oct 22.
- Espeland MA, Miller ME, Goveas JS, Hogan PE, Coker LH, Williamson J, Naughton M, Resnick SM; Whisca Study Group. Cognitive function and fine motor speed in older women with diabetes mellitus: results from the women's health initiative study of cognitive aging. J Womens Health (Larchmt). 2011 Oct;20(10):1435-43. doi: 10.1089/jwh.2011.2812. Epub 2011 Aug 5.
- Espeland MA, Brunner RL, Hogan PE, Rapp SR, Coker LH, Legault C, Granek I, Resnick SM; Women's Health Initiative Study of Cognitive Aging Study Group. Long-term effects of conjugated equine estrogen therapies on domain-specific cognitive function: results from the Women's Health Initiative study of cognitive aging extension. J Am Geriatr Soc. 2010 Jul;58(7):1263-71. doi: 10.1111/j.1532-5415.2010.02953.x.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- NO1-AG-9-2115
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .